An interventional study of general practice follow-up and ear-nose-throat (ENT) specialist follow-up in Otitis, sponsored by Norwegian University of Science and Technology. Completed at 6 sites in Norway. Open to participants aged 3 Years to 10 Years. Per ClinicalTrials.gov, last updated 2023-11-02.
Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Health services research
A large number of children with otitis media undergo surgery with ventilation tubes (VTs) placed in the tympanic membrane. This is done to improve hearing and speech development and to reduce ear complaints. The long-term results of VTs are unclear. Follow-up care is required to assure that the tubes are functional, hearing loss has been corrected, and potential complications are properly diagnosed and managed. Guidelines regarding follow-up care give different advices concerning when, how and by whom the controls should be made.
The primary goal of this study is to investigate if follow-up care after surgery with VTs of children aged 3-10 years can be done by general practitioners instead of specialists without negative consequences for the patient.
In the study the child's hearing and speech development, middle ear function, subjective complaints and complications will be assessed. User satisfaction and other aspects related to the quality of control will also be assessed.
If the study shows that follow-ups after surgery with VTs can be done on the level of primary care without loss of care quality, specialist health care services will be spared and cost-effectiveness for the overall healthcare system will improve.
Remark: the change in age range of included children from 4-10 to 3-10 was approved by REK (ethics committee) in November 2018.
80 studies on the registry are indexed under Otitis; 10 are open to participants now.
This study's enrollment of 322 is above the median of 183 across 54 interventional studies indexed under Otitis.
Browse Otitis studies →Norwegian University of Science and Technology is the lead sponsor of 495 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
post-surgery follow-up by general practitioner
Procedure: general practice follow-up
post-surgery follow-up by ear-nose-throat (ENT) specialist
Procedure: ear-nose-throat (ENT) specialist follow-up
Post-surgery follow-up by general practitioner
Post-surgery follow-up by ear-nose-throat (ENT) specialist
audiogram
pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz
Time frame: 2 years
audiogram
pure tone thresholds in decibel (dB) at 0.25-0.5-1-2-4 kHz
Time frame: 4 years
Plan to share: Undecided
Ran from Aug 2017 to primary completion in Nov 2023, 74 months.
Of 19 interventional studies with no phase under Otitis, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 74. This study's 74 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Norwegian University of Science and Technology →